MAUDE Adverse Event Report: MEDIVATORS CENTRISOL LIQUID BICARBONATE CONCENTRATE; DIALYSIS CONCENTRATE FOR HEMODIALYSIS

Model Number	MB330-L-B
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	07/25/2016
Additional Manufacturer Narrative
This complaint was received through medivators distributor, fresenius medical care (fmc) post market surveillance department via letter of complaint.It was reported that 4 patients experienced nausea and vomiting after receiving dialysis.Medivators liquid bicarbonate concentrate was used in the dialysate solution for patient dialysis treatment.Medivators ra immediately contacted this facility for additional information.In this discussion, it was reported that all patients are currently stable.One patient was hospitalized because they experienced extreme vomiting.Only one lot number was provided (780857) by the facility.Preliminary analysis of this lot from testing on medivators' reserve sample and batch record review demonstrated that the bicarbonate met specification.Medivators was unable to receive product back and fmc did not provide lot information.It was also reported that the patients all receive home dialysis using the fresenius k@home dialysis machine and fresenius acid concentrate.It was mentioned that the patients' machines were operating normally and dialysate meters were within the appropriate limits prior to use.A medical report went out to all fresenius doctors and they responded that there was no trend in these symptoms amongst other patients using medivators liquid bicarbonate solution.Medivators ra and qa met with the renal clinical specialist to discuss this case.It was mentioned that nausea and vomiting is the most common side-effect for patients on dialysis.This complaint will continue to be maintained within medivators complaint system.
Event or Problem Description
The case states patients experienced nausea and vomiting after receiving hemodialysis treatment.Medivators liquid sodium bicarbonate was a component used in their dialysate solution.

• Brand Name: CENTRISOL LIQUID BICARBONATE CONCENTRATE
• Common Device Name: DIALYSIS CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 5853244
• Report Number: 2150060-2016-00031
• Device Sequence Number: 19139347
• Product Code: KPO
• UDI-Device Identifier: 30677964000400
• UDI-Public: 30677964000400
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K843963/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring,Inspection
• Type of Report: Initial
• Report Date (Section B): 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MB330-L-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Hospitalization